FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K Number: K982709
·
Decision Sep 3, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
- K Number
- K982709
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alexon - Trend, Inc.
- Date Received
- August 4, 1998
- Decision Date
- September 3, 1998
- Product Code
- MHJ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHJ | Cryptosporidium Spp. | FDA class 2 | Microbiology |
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